Various medical procedures, particularly cardiology related procedures, involve accessing a corporeal vessel or other bodily lumen through a percutaneous sheath. Accessing the vessel necessarily requires the formation of a hole or opening in the vessel wall. The hole allows medical equipment such as catheters to be inserted into the vessel so that the physician can perform the desired medical procedure. After the medical procedure has been completed, the sheath must eventually be removed from the vessel and the access hole in the vessel wall must be closed.
Historically, access holes to blood vessels were closed by applying prolonged manual pressure over the puncture site by a physician or other trained medical professional. In most situations, the time involved was extensive, especially if anticoagulants and/or thrombolytic agents were used during the procedure. Using manual pressure to close the access holes resulted in greater time demands on the medical professional and also increased the patient's recovery time. Consequently, the expense associated with the procedure also increased. The discomfort and delay in mobilization for patients resulting from this prolonged manual pressure is significant.
In response to these problems, a number of vascular closure devices have been developed to close an access hole in a vessel wall more efficiently. For example, an access opening in the vessel wall may be closed by positioning a resorbable sealing plug adjacent to the hole or sandwiching the hole between the sealing plug and an anchor. These devices have been found to be highly effective, but they may not be suitable for every situation. Also, these devices leave the anchor in the vessel, which may not be desirable in certain situations. In an effort to overcome some of these aspects of current vascular closure devices, closure devices utilizing balloons have been investigated. These closure devices may be used to close an access hole to a blood vessel by inserting the balloon through the opening in the vessel wall, inflating the balloon, pulling the balloon against the inner wall of the vessel, introducing a sealing material to the external side of the hole in the vessel wall, and withdrawing the balloon catheter.
Unfortunately, there are a number of problems associated with using balloon type closure devices. As illustrated in FIGS. 1 and 2, one of the problems associated with these closure devices is that the balloon does not contact the vessel wall in a uniform manner. FIGS. 1 and 2 show a vascular closure device 50 inserted into a blood vessel 52. The vascular closure device 50 includes a body 54 and a balloon 56 positioned perpendicular to the body 54. As the balloon 56 is pulled up against the wall 58, the uppermost tip contacts the wall 58 first. As the balloon 56 is pulled further, increasing amounts of the balloon 56 contact the wall 58 until finally the entire balloon 56 is in contact with the wall 58 as shown in FIG. 2. Because the balloon 56 contacts the wall 58 in this way, the balloon 56 often deforms as shown in FIG. 2 resulting in a poor seal between the balloon 56 and the wall 58 of the blood vessel 52. The poor seal may allow the sealing material to pass through the hole in the blood vessel 52 and into the bloodstream. Also, it is difficult for the physician or other medical professional to determine when the balloon 56 is in position since the balloon 56 tends to provide a similar amount of tactile feedback from the time the balloon 56 first contacts the wall 58 and the time the balloon 56 is fully in position as shown in FIG. 2. The lack of reliable tactile feedback has caused physicians, in some instances, to pull so hard on the balloon 56 that the balloon 56 ruptures or pulls through the hole in the blood vessel 52.
The problems with vascular closure devices that utilize balloons have greatly hindered commercial acceptance of these type of products. Accordingly, it would be advantageous to provide an improved vascular closure device that utilizes a balloon.